FDA 510(k)

CLEX

K-Number: K833463 · 1983-11-21

Decision Date1983-11-21

Product CodeKIS

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

CLEX is the device name listed in this FDA 510(k) record. The listed applicant is Dextran Products, Ltd.. It received FDA 510(k) clearance on 1983-11-21 under 510(k) number K833463. The device is classified under product code KIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CLEX?

CLEX is a medical device that received FDA 510(k) clearance on 1983-11-21. The listed applicant is Dextran Products, Ltd.. The 510(k) number is K833463.

When did CLEX receive FDA 510(k) clearance?

CLEX received FDA 510(k) clearance on 1983-11-21, under 510(k) number K833463.

Who is the listed applicant for CLEX?

The FDA 510(k) record lists Dextran Products, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CLEX?

The FDA product code for CLEX is KIS.

Related Devices (Code: KIS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K881287ANIMAL AND HUMAN SERACell Culture Laboratories K880471BOVINE CALF SERUM SUPPLEMENTED #A-2159Hyclone Laboratories, Inc.K880470BOVINE CALF SERUM CATALOG #A-2119Hyclone Laboratories, Inc.K872847SOLCOSERYL TISSUE CULTURE GROWTH SUPPLEMENTCandace Lane Corp.K870580MLC NORMAL SERUMRjo Biologicals, Inc.K870938FETAL BOVINE SERUMHyclone Laboratories, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.